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FPS HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT Good Manufacturing Practice for Cosmetics - Audit 1 Els Vrindts Inspection Service Consumption Products Federal Public Service for Health, Food Chain Safety and Environment Belgium

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Page 1: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT

Good Manufacturing Practice for

Cosmetics - Audit

1

Els Vrindts

Inspection Service Consumption Products

Federal Public Service for Health, Food Chain Safety

and Environment

Belgium

Page 2: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

How to prepare for a GMP audit

Approach to audit of GMP for cosmetics

From materials to finished product

Be prepared – internal check

tips from the field

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Page 3: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Good Manufacturing Practices

Production suitable to ensure the desired quality of

product - Quality assurance

Looking at the whole production process, taking care of

every step

Knowing the critical points

Collecting information and learning

Correcting where necessary

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Page 4: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Good Manufacturing Practices - themes

• Organisation

• People

• Buildings and infrastructure

• Materials

• Procedures

• Documentation

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Page 5: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Approach to GMP audit

Is this site suitable for the type and quantity of

cosmetics produced ?

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Page 6: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

An approach to audit

1. General view of the site • number of people

• Type of products, yearly production

• History of the site(s)

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Page 7: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

An approach to audit

1. General view of the site • Organigram

• Education / qualification of production and

quality control persons

• New worker programs, including hygiene

• continued training of personnel

• Production site & material flows (plan)

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Page 8: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Approach to GMP audit

2. Materials

Ingredients, packaging materials

• Specifications, Quality checks, Certificate of analysis

• Labeling and tracebility of materials

• quarantaine

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Page 9: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Approach to GMP audit

2. Materials

• WATER

• specific quality, treatment, monitoring

• Stock & shipment

• Climate, pest control

• Keeping the quality of stock (closed containers, … )

• stock management

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Page 10: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Approach to GMP audit

3. Quality control - laboratory

• Procedures• Checks of ingredients, packaging, bulk, final product

• > (communication of) release of batches

• Lab equipment, calibration

• Documentation

• Sampling

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Page 11: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Approach to GMP audit

4. Production

Wheighing, mixing, filling

• walls & floors, pest control, material/product flows

• equipment

• procedures

• cleaning, clear line, production, …

• documentation

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Page 12: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Approach to GMP audit

4. Production

Wheighing, mixing, filling

• Tracebility

What if the bulk product looks/smells funny ?

Personnel knows what to do in case of a problem ?

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Page 13: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Approach to GMP audit

Problems & complaints

• Procedures in place for recall

Subcontracting

• specifications !

• Subcontractor : able to meet requirements?

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Page 14: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Approach to GMP audit

Proper treatment of wastes

Return of products > identified, properly stored

Labeling of products

Product Information File

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Page 15: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Be prepared

Self test: is my firm following the GMP?Procedures are in place?

clear and understood?

Instructions are respected?

Internal audit

Ask external view, before official audit

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Page 16: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

Be prepared

Documentation

Records available and up to date?

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Page 17: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

tips

Ingredient specifications, including impurities

! changes in supplier or quality of ingredient

Procedure adapted to site

formula/production methods yield different results in

different sites

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Page 18: Good Manufacturing Practice for Cosmetics - Auditcrcc2017.com/Sites/377/Editor/Documents/Els Vrindts... · Good Manufacturing Practice for Cosmetics - Audit ... and Environment Belgium

FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT

tips

Quality control adapted to product and consumer

profile

! hospitals, health care > consumers with lower

immune defense; adapted testing of microbial

quality

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